Pharmaceuticals

Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025

--Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne compared with placebo. --Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. Treatment emergent adverse events (TEAEs)...

2025-09-18 07:30 1837

Mabwell Bioscience and Aditum Bio Announce Formation of Kalexo Bio to Advance Innovative siRNA Therapy for Cardiovascular Disorders

SHANGHAI and OAKLAND, Calif., Sept. 17, 2025 /PRNewswire/ -- Mabwell (Shanghai) Bioscience Co., Ltd. (688062.SH) and Aditum Bio today announced the launch of Kalexo Bio, a new company formed in conjunction with an exclusive global license agreement to develop2MW7141, a novel dual-target siRNA cand...

2025-09-17 20:00 1710

Alteogen Receives European Commission Approval for Aflibercept Biosimilar, EYLUXVI® (ALT-L9)

* EYLUXVI® is the second biosimilar approved for Alteogen following the launch of the Herceptin® biosimilar in China through its partner Qilu Pharmaceutical. DAEJEON, South Korea, Sept. 17, 2025 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the European Commission (EC) has ...

2025-09-17 15:40 2498

111, Inc. Announces Second Quarter 2025 Unaudited Financial Results

* Maintained Quarterly Operational Profitability * Operating Expenses as a Percentage of Revenues Decreased 20 Basis Points YoY * Maintained Positive Operating Cash Flow in the First Half of the Year SHANGHAI, Sept. 17, 2025 /PRNewswire/ -- 111, Inc. ("111" or the "Company") (NASDAQ: YI), a l...

2025-09-17 14:00 4568

Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)

WUXI, China, Sept. 17, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – have received GMP certification from Türkiye İlaç ve ...

2025-09-17 12:00 1953

Kexing Biopharm's Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Registered with FDA DMF

SHENZHEN, China, Sept. 16, 2025 /PRNewswire/ -- Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S. FDA. Exosomes, as a next-generation bioactive carr...

2025-09-17 10:30 1878

Ascletis Presented Results from Cohorts 1 and 2 of 28-day Multiple Ascending Dose Study of Its Oral Small Molecule GLP-1R Agonist ASC30 at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting

-          ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment. -          ASC30 tablet's higher efficacy is supported by its higher oral drug exposures. -          ASC30 is safe and well tolerated with only mild-...

2025-09-17 07:30 1742

Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)

HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of acute myeloid leukemia (A...

2025-09-16 10:27 1583

Innovent to Present Multiple R&D Results of General Biomedicine Pipeline at the 34th EADV Congress 2025

SAN FRANCISCO and SUZHOU, China, Sept. 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metaboli...

2025-09-16 09:00 1821

HitGen Partner BioAge Labs Initiates Phase 1 Clinical Study of BGE-102, a Novel Brain-Penetrant NLRP3 inhibitor

* BGE-102, an orally available, brain-penetrant NLRP3 inhibitor, was developed from a hit compound identified using HitGen's industry-leading DEL technology platform, highlighting the value of DEL to accelerate innovative drug development. * The initiation of the BGE-102 Phase 1 clinical stud...

2025-09-15 21:30 1780

Korea reinforces biopharma leadership at Global Bio Conference 2025

SEOUL, South Korea, Sept. 15, 2025 /PRNewswire/ -- This is an article published in The Korea Herald: The Ministry of Food and Drug Safety on Thursday announced its successful hosting of the Global Bio Conference 2025 inSeoul last week, under the theme "Bio, Navigating Infinite Possibilities." T...

2025-09-15 20:30 1631

Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class P...

2025-09-15 12:11 1900

Phrontline Biopharma Announces First Patient Dosed in Phase 1 Clinical Trial of TJ101

SHANGHAI and SUZHOU, China, Sept. 14, 2025 /PRNewswire/ -- Phrontline Biopharma , a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), today announced that the first patient has been successfully dosed in its Phase 1 clinical trial of TJ101, the com...

2025-09-15 08:00 1461

LakeShore Biopharma Announces Receipt of Delisting Determination Letter from Nasdaq

BEIJING, Sept. 12, 2025 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) ("LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious ...

2025-09-12 20:00 2423

Zhimeng Biopharma's Investigational Drug Approved to Initiate Phase 2 Epilepsy Clinical Trial in China

SHANGHAI, Sept. 11, 2025 /PRNewswire/ -- Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma") announced that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has recently received clinical trial approval from the Center for Drug Evaluation (CDE) ofChina's Nat...

2025-09-12 00:00 1915

C-Ray Therapeutics Supports Mednovo's Phase III Clinical Trial with First Patient Dosed for Lutetium [177Lu] Oxodotreotide Injection

CHENGDU, China, Sept. 10, 2025 /PRNewswire/ -- August 22, 2025, Mednovo Group Co., Ltd. ("Mednovo") announced that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection, a Class 3 targeted radiotherapeutic drug. As the exclusive...

2025-09-10 21:30 1180

LakeShore Biopharma Announces Appointment of Independent Financial Advisor and Legal Counsel to the Special Committee

BEIJING, Sept. 10, 2025 /PRNewswire/ -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB,  "LakeShore Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious ...

2025-09-10 20:10 1726

ImmVira Announces First-in-Human Data of Engineered Exosome MVR-EX105 for Fat Reduction and Muscle Preservation by Topical Application at 2025 Annual Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders

SUZHOU, China, Sept. 9, 2025 /PRNewswire/ -- ImmVira Group ("ImmVira" or the "Company") recently announced that its lead engineered exosome candidate, MVR-EX105 ("EX105") is featured in a poster presentation at the 2025 Annual Congress of the International Federation for the Surgery of Obesity an...

2025-09-10 10:49 1224

iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for its Flagship Product NouvNeu001

CHENGDU, China, Sept. 9, 2025 /PRNewswire/ -- iRegene Therapeutics (Chengdu) Co., Ltd. ("iRegene" or the "Company"), a biotechnology company pioneering chemically induced allogeneic cell therapy, announced on September 4th the successful completion of its Series B+ financing round, co-led by Nort...

2025-09-09 21:00 1374

Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC

SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in...

2025-09-09 18:00 1333
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